Jelco 305706Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Jelco (101)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10351688071149), received between Mar 12, 2018 and Nov 14, 2024 — classified as 3 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Break” (13 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break13
- Material Twisted/Bent5
- Component Missing1
- Deformation Due to Compressive Stress1
- Dull, Blunt1
- Fluid/Blood Leak1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Foreign Body In Patient6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Discomfort1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 14, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE CATHETER WAS LEAKING BLOOD. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20687052 ↗InjuryJun 7, 2022Break; Break
IT WAS REPORTED THAT THE IV BEING REMOVED FROM PATIENT DISCHARGE, UPON REMOVAL THE RN NOTICE THE CATHETER WAS MISSING. ULTRASOUND COMPLETED AND FOUND 3/4 OF THE 1" CATHETER IN THE CEPHALIC VEIN. MD PERFORMED PROCEDURE AT BEDSIDE TO CUT CATHETER FROM THE VEIN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14621324 ↗InjuryApr 21, 2022Break; Break
IT WAS REPORTED THAT APPROXIMATELY THREE-FOURTHS OF THE ONE INCH CATHETER BROKE OFF IN THE PATIENT'S VEIN UPON REMOVAL FROM THE ARM. THE DOCTOR HAD TO CUT OPEN THE VEIN TO RETRIEVE THE CATHETER.
Patient problems: Foreign Body In Patient
MAUDE report 14168218 ↗MalfunctionMar 20, 2022Break; Break
IT WAS REPORTED THAT CATHETER SHEAR OCCURRED WHILE IN THE PATIENT'S VEIN. ANOTHER DEVICE WAS ABLE TO BE USED TO COMPLETE THE PROCEDURE.
Patient problems: Foreign Body In Patient
MAUDE report 13829795 ↗MalfunctionMar 18, 2022Break; Break
IT WAS REPORTED THAT CATHETER SHEAR OCCURRED WHILE IN THE PATIENT'S VEIN. ANOTHER DEVICE WAS ABLE TO BE USED TO COMPLETE THE PROCEDURE.
Patient problems: Foreign Body In Patient
MAUDE report 13808137 ↗MalfunctionMar 18, 2022Break; Break
IT WAS REPORTED THAT CATHETER SHEAR OCCURRED WHILE IN THE PATIENT'S VEIN. ANOTHER DEVICE WAS ABLE TO BE USED TO COMPLETE THE PROCEDURE.
Patient problems: Foreign Body In Patient
MAUDE report 13806627 ↗MalfunctionMar 18, 2022Break; Break
IT WAS REPORTED THAT CATHETER SHEAR OCCURRED WHILE IN THE PATIENT'S VEIN. ANOTHER DEVICE WAS ABLE TO BE USED TO COMPLETE THE PROCEDURE.
Patient problems: Foreign Body In Patient
MAUDE report 13806619 ↗MalfunctionMar 18, 2022Break; Break
IT WAS REPORTED THAT CATHETER SHEAR OCCURRED WHILE IN THE PATIENT'S VEIN. ANOTHER DEVICE WAS ABLE TO BE USED TO COMPLETE THE PROCEDURE.
Patient problems: Foreign Body In Patient
MAUDE report 13804670 ↗MalfunctionSep 16, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETERS (PIVC)/JELCO SAFETY PROTECTIV CATHETER, BROKE/BENT UPON INSERTION. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12481043 ↗MalfunctionSep 16, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETERS (PIVC)/JELCO SAFETY PROTECTIV CATHETER, BROKE/BENT UPON INSERTION. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12481011 ↗MalfunctionSep 16, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETERS (PIVC)/JELCO SAFETY PROTECTIV CATHETER, BROKE/BENT UPON INSERTION. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12480931 ↗MalfunctionSep 16, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETERS (PIVC)/JELCO SAFETY PROTECTIV CATHETER, BROKE/BENT UPON INSERTION. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12480848 ↗MalfunctionSep 16, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETERS (PIVC)/JELCO SAFETY PROTECTIV CATHETER, BROKE/BENT UPON INSERTION. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12480786 ↗MalfunctionSep 16, 2021Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETERS (PIVC)/JELCO SAFETY PROTECTIV CATHETER, BROKE/BENT UPON INSERTION. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12480676 ↗InjurySep 3, 2019Material Separation; Component Missing
RN WAS STARTING AN IV ON THIS PT IN THE LEFT FOREARM USING A 20 GAUGE PROCTIV ANGIO CATHETER. AFTER INSERTING THE CATHETER, THE RN WAS ACTIVATING THE SHARP SAFETY MECHANISM TO REMOVE THE NEEDLE AND HEARD NO CLICK AND THE NEEDLE KEPT COMING AND THE PINK HUB JUST FELL TO THE GROUND. THE WHITE TEFLON PIECE WAS MISSING. EXAMINED TO PINK HUB AND IT APPEARS THE WHITE TEFLON PIECE WAS THERE BUT WAS TORN AWAY. THE PT'S ARM WAS EXAMINED, COULD NOT FEEL ANY HARD AREAS. THE PT'S ARM WAS XRAYED FROM FINGER TIPS TO COLLAR BONE, NOTHING WAS DETECTED. THE SITUATION WAS EXPLAINED TO THE PT AND FAMILY MEMBER BY THE PHYSICIAN AND RN. THE PT WAS SENT TO THE EMERGENCY ROOM VIA AMBULANCE FOR FURTHER STUDIES / CT SCAN / MRI TO ATTEMPT TO LOCATE THE DEVICE. FDA SAFETY REPORT ID# (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8960469 ↗MalfunctionMar 12, 2018Dull, Blunt; Dull, Blunt
IT WAS REPORTED THAT A JELCO® PROTECTIV® SAFETY I.V. CATHETER WAS DULL, CAUSING PATIENT "DISCOMFORT". NO INJURY WAS REPORTED.
Patient problems: Discomfort
MAUDE report 7332053 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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